MODIFICATION
A -- RFP for Pre-Clinical Safety, Toxicology, Pharmacokinetic/Dynamic, & Biodistribution Studies Supporting Investigational New Drug Applications of Small Molecule Therapeutics for Spinal Muscular Atrophy
- Notice Date
- 8/1/2007
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Science Applications International Corporation (SAIC)(NINDS Prime Contractor), 5340 Spectrum Drive, Suite N, Frederick, MD, 21703-7357, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-SMA11
- Response Due
- 9/27/2007
- Archive Date
- 10/12/2007
- Point of Contact
- Adam Book, Senior Life Scientist, Phone 301-228-3114,
- E-Mail Address
-
SMAProject-fd@saic.com
- Description
- The SMA Project (http://www.smaproject.org) expects to release a Request for Proposals (RFP) within the next 30 days to identify and fund facilities capable of providing the necessary research and development support for an Investigational New Drug (IND) submission in a format acceptable to the U.S. Food and Drug Administration (FDA). The intention is to award a subcontract to a facility capable of conducting safety, toxicology, pharmacokinetic/ dynamic, and biodistribution studies with candidate small molecule compounds that act as therapeutic agents for SMA. These studies will be done in partial fulfillment of the requirements for submitting an IND application to the FDA. Science Applications International Corporation (SAIC), on behalf of the Government, shall supply the Offeror with a small amount of each candidate therapeutic compound. The Offeror will be required to prepare and deliver, for each selected therapeutic compound provided by SAIC for testing, a specific Test Implementation Plan including a proposed budget for the specific testing activities. Activities within the facility shall be highly coordinated with efficacy testing activities outside the facility by SAIC. SAIC shall require from the Offeror preclinical development data that are required by the FDA for filing successful IND applications. Offers will be due approximately 28 days from the release of the RFP. Interested Offerors should sign up for the SMA Project ListServ (http://www.smaproject.org/list-serv.asp). ListServ registrants will receive notice the day the RFP is released. In addition, a notice will be posted in FedBizOpps on the day of release. Relevant documents will be available through the Solicitations page of the SMA Project website at http://www.smaproject.org/solicitations.html. The National Institute for Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) launched The SMA Project: A Collaborative Program to Accelerate Therapeutics Development for Spinal Muscular Atrophy in September 2003. This program funds milestone-driven research aimed at identifying and rapidly developing a treatment for SMA, a paralyzing neurodegenerative disease of childhood. SAIC is supporting the NINDS in the management of this program. Any responsible Offeror may submit a proposal to be considered by SAIC.
- Place of Performance
- Address: Offeror's facilities.
- Zip Code: 00000
- Country: UNITED STATES
- Zip Code: 00000
- Record
- SN01358592-W 20070803/070801220706 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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